Pharmaceutical Technology Editors

CordenPharma announced the completion of a new highly potent process bay for APIs at the company’s Colorado facility.

The companies will collaborate the manufacture of personalized cancer vaccines.

Laboratoire Sintyl S.A. received an FDA warning letter for CGMP quality violations.

Wallace Cameron International was cited for not registering its Wishaw, Scotland facility with FDA.

Recipharm launched a showcase line to demonstrate the company’s new serialization solutions.

Piramal entered into an agreement with Janssen Pharmaceuticals to acquire five of the company’s injectable products.

FDA warned Nippon Fine Chemical Co. for refusing to allow FDA investigators to inspect sections of the company’s laboratory and equipment.

HHS entered into a contract with BioProtection Systems Corp. for commercial manufacturing tests of an Ebola vaccine.

Marken announced the opening of a new depot and logistics operations center in Argentina.

Gamida Cell was granted FDA Breakthrough Therapy Designation for NiCord, a novel graft modality for bone marrow transplantation.

The company revealed its new Always Solving corporate identity following its eventual separation from Valvoline.

The companies entered into a collaboration and license agreement for Crescendo’s Humabody-based therapeutics.

The agency’s Patient-Focused Drug Development program completed its commitment ahead of schedule.

WuXi AppTec’s new biomanufacturing facility is its third facility in the Philadelphia, PA Navy Yard.

The companies are collaborating on the commercialization of two biosimilar candidates in the US and Canada.

A report from the European Union Intellectual Property Office shows that the EU loses approximately €10.2 billion a year due to counterfeit medicines.

Cambrex’s novel synthesis of Dronederone intermediate was recognized for its excellence in API development.

GEA’s ConsiGma, which is a multipurpose continuous manufacturing platform, won the award for excellence in manufacturing technology and equipment at the 2016 CPhI Pharma Awards.

Capsugel’s intrinsically enteric capsule technology provides enteric protection and delayed release without a functional coating. Merck’s Parteck SRP 80 sustained-release excipient is well suited for direct compression.

Pyclear Protection replaces the use of antimicrobial preservatives in multi-dose products without any change to the primary packaging and has no impact on the manufacturing process.

The Intelligent Control Inhaler is an intuitive, fully-integrated device delivering accurate doses of medication to patients, while providing on-screen instructions for use and feedback to the patient and healthcare provider via an app.

Novasep’s BioSC Lab chromatography is a flexible equipment that enables operations from one column up to six columns in batch, parallel batch, or continuous processing with all media and membrane types.

Pharma Venture’s approach in tackling supply-chain, logistic, and distribution challenges in the MENA region was recognized at the CPhI Pharma Awards.

The winners for all 12 categories in the 2016 CPhI Pharma Awards have been announced.

Indena’s Centella asiatica project in Madagascar focused on improving the living conditions of the local communities involved in Centella asiatica harvesting.

The OptiForm Solution Suite platform offers easy, simple, fast, and cost-effective approaches for both small and macromolecules in early development phases.

The CPhI Pharma Award for Excellence in Analysis, Testing, and Quality Control went to B&W Tek for its handheld laser induced breakdown spectroscopy (LIBS) analyzer, NanoLIBS, which has been developed for rapid identification of solid materials based on elemental analysis. The instrument features a raster scan using a high repetition rate class 3B laser allowing for detection of elements including C, Li, and Be.

The winning entry was Merck’s Emprove program, which facilitates risk assessment and supplier qualification by providing instant, online access to regulatory and technical information on hundreds of products used in pharmaceutical and biopharmaceutical manufacturing.

The time and resources required to finalize post-approval changes may be preventing manufacturers from modernizing facilities, or even scouting for new technology.

The company announced that it will build a new manufacturing facility at the GMR Aerospace Park at the Rajiv Gandhi International Airport in India.